<b>Background:</b> Comparative assessments of the vascular and upper gastrointestinal risks of different regimens of non-steroidal anti-inflammatory drugs (NSAIDs) are required. <b>Methods:</b> Meta-analyses were conducted, using individual participant data where possible, of placebo-controlled trials of a selective cyclo-oxygenase [COX]-2 inhibitor ('coxib') or traditional NSAID, or randomised trials of a coxib versus traditional NSAIDs. A prespecified subdivision of traditional NSAID regimens of those with antiplatelet activity (mainly naproxen) and those without (mainly diclofenac) was made. Primary outcomes were major vascular events (MVEs; nonfatal myocardial infarction, nonfatal stroke or vascular death) and upper gastrointestinal complications (UGICs; perforation, obstruction or bleed). <b>Findings:</b> Searches identified 788 trials: 200 comparisons of a coxib vs placebo (88,604 participants, mean follow-up 0.60 years), 206 comparisons of a traditional NSAID vs placebo (43,482 participants, 0.46 years) and 149 comparisons of a coxib vs traditional NSAID (137,466 participants, mean follow-up 0.95 years). Compared to placebo, allocation to a coxib increased the risk of MVEs (rate ratio 1.38, 95&percnt; CI 1.14-1.66), vascular mortality (1.58, 1.11-2.24) and UGICs (1.81, 1.17-2.81). Overall, in the population studied, coxibs were associated with three additional major vascular events (one fatal) and two (rarely fatal) upper gastrointestinal complications per 1000 person-years exposure. There was no evidence of heterogeneity by duration of follow-up, coxib type, dose (other than for celecoxib), or patient characteristics, for the primary outcomes. The risk of MVEs for traditional NSAIDs without antiplatelet activity (mostly diclofenac 75mg bd or ibuprofen 800mg tds) were comparable to coxibs (1.40, 1.15-1.72); but the risk of UGICs (1.98, 1.39-2.84) was significantly greater. For traditional NSAIDs with antiplatelet activity (mostly naproxen 500mg bd) there were no significant excess of MVEs (0.84, 0.66-1.08), but UGICs were substantially increased (4.06, 2.85-5.78). Both coxibs and traditional NSAIDs increased risk of hospitalisation for heart failure by about two-fold. <b>Interpretation:</b> The vascular and upper gastrointestinal risks of coxibs and high-dose tNSAID regimens can be predicted, allowing the choice of analgesia to be tailored for particular patients.

In this thesis, I report the results from the first randomized field experiments conducted in collaboration with party-affiliated candidates and campaigns in the United Kingdom. The papers presented as part of this thesis test both the limits and possibilities of campaign influence, in a partisan political environment. During election campaigns parties provide signals to voters, voluntarily or involuntarily imposing a structure, and thereby constraints, on individuals’ electoral decisions. By integrating insights about heuristic and social decision-making into the experimental campaign literature, I formulate testable hypotheses about the direct and indirect effects of party cues on campaign mobilization and persuasion. The first paper, The Heuristic Function of Party Affiliation in Voter Mobilization Campaigns, addresses how the provision of party cues, used during campaign phone calls, affects turnout among party supporters, opponents and unattached voters. The second paper on Household Partisan Composition and Voter Mobilization, explores the spillover effects from the previous experiment, testing whether campaign-induced mobilization between household members is conditioned by the partisan composition of a household, and the partisan intensity of a campaign message. Paper three investigates if candidates who are Reaching Across The Partisan Divide can win over supporters of rival parties. In the fourth paper, I test if Impersonal, But Noticeable methods of voter contact, such as door hangers and text messages, affect the turnout decisions of partisans and unattached voters. The final paper, The National Effects of Subnational Representation, highlights the importance of local party organization for the outcomes of national elections. The results of this thesis show the electoral consequences of direct and indirect interactions between campaigns and voters of different partisanship, and point to strategies that allow constituency campaigns to successfully navigate challenging partisan environments.

Hybridity, as it is currently understood in the Peace and Conflict Studies (PCS) and International Relations (IR) literature, is defined by the complex interactions between ‘the liberal peace' and ‘the local'. However, under this theoretical liberal-local rubric, the ways in which power is practiced has already been determined; how resistance is expressed and the forms it assumes have already been established. While it has yielded numerous important insights into how power circulates and resistance manifests in peacebuilding operations, the theoretical approach conceals other significant dynamics which escape detection by ‘the liberal peace' and ‘the local'. However, these undetected dimensions of hybridity comprise the very processes that emerge in ways which destabilise the boundaries between ‘the liberal peace' and ‘the local' and reshape the contours of the emerging post-liberal peace. Instead of accepting the liberal-local distinction which defines this theoretical hybridity, this thesis advances an alternative methodological approach to exploring the tensions at play in peacebuilding projects. Rather than deploying theoretical distinctions in order to explain or understand complex hybrid processes, this thesis develops a methodological strategy for exploring the tensions between how actors design a peacebuilding project and how that project changes as actors work to translate that project into complex, everyday living sites (Callon, 1986; Law, 1997; Akrich, 1992). This tension is expressed as practical hybridity. The process of practical hybridity unfolds as the concrete material changes, modifications, and adaptations that emerge as actors appropriate and contingently translate organised practices in new ways and for different purposes. Through an ongoing process of practical hybridity, the boundaries and distinction which define the distinction between ‘the liberal peace' and ‘the local' become increasingly unstable. Amidst this instability, the practices which characterised ‘the liberal peace' are becoming stretched into a post-liberal peace. Drawing on the work of Richmond (2011a; Richmond & Mitchell, 2012), Latour (1987b; 1988; 2004), and Schatzki (2002), and based on over five months of field research, this this thesis traces the process of practical hybridity at play during the implementation and evaluation of a peacebuilding project in Liberia. I participated as a research assistant on a Randomised Control Trial (RCT), implemented by a small research team under the auspices of the Oxford University's Centre for the Study of African Economies (CSAE). The team was assessing the impact of a legal empowerment programme managed by The Carter Center: the Community Justice Advisor (CJA) programme. As the CSAE's evaluation of the CJA programme unfolded, many dynamics associated with theoretical liberal-local hybridity surfaced; however, it also became apparent that this theoretical formulation obscured important dimensions which were reshaping what peacebuilding practice is in the process of becoming in the emerging post-liberal world.

Chronische Schmerzerkrankungen beeinflussen die Arbeitsfähigkeit deutlich. Ziel dieser systematischen Übersichtsarbeit ist es, arbeitsbezogene Studienendpunkte in randomisierten, placebokontrollierten Studien zu chronischen Schmerzerkrankungen und schmerzhaften rheumatologischen Erkrankungen zu analysieren. Datenbanktreffer einer Literaturrecherche in Medline (Pubmed) wurden als Abstracts gesichtet und potentiell relevante Studien danach im Volltext beurteilt. Die methodologische Studienqualität wurde mit der Oxford Quality Scale (OQS) bewertet. Verfügbare arbeitsbezogene und schmerzbezogene Endpunkte wurden in Meta-Analysen mit Hilfe von einem „fixed effect model“ oder einem „random effects model“ zusammengefasst. Lineare Regressionen zwischen arbeitsbezogenen Endpunkten und schmerzbezogenen Endpunkten wurden durchgeführt. Insgesamt 31 Publikationen mit einer Gesamtzahl von 11434 Patienten berichten über arbeitsbezogene Studienendpunkte; dies waren nur ungefähr 0,23% aller relevanten Publikationen. Eine Meta-Analyse aller arbeitsbezogenen Endpunkte, ohne Unterteilung nach vorgenommener Behandlung und der spezifischen vorliegenden Erkrankung, konnte einen allgemeinen Behandlungserfolg von 0,35, ausgedrückt als standardisierte Mittelwertsdifferenz (SMD), mit einem 95%-Konfidenzintervall (95%-KI) von 0,21 bis 0,50 beschreiben. Eine umfassende Meta-Analyse der Schmerzendpunkte derselben Studien ergab eine allgemeine Verbesserung bezüglich schmerzbezogener Endpunkte von 0,40, ausgedrückt als SMD (95%-KI: 0,25; 0,55). Weitere Meta-Analysen zeigten statistisch signifikante Verbesserungen in den Behandlungsgruppen für die folgenden Parameter: Beeinträchtigungen bei der Arbeit (0,62 Punkte auf einer 0- bis 10-Punkte-Skala; 95%-KI: 0,45; 0,79), Arbeitsproduktivität (SMD 0,53; 95%-KI: 0,18; 0,88), 30%ige Schmerzverbesserung relativ zu Studienbeginn (ausgedrückt als Verbesserung des relativen Risikos (RR) von 33%; 95%-KI: 15%; 53%) und 50%ige Schmerzverbesserung relativ zu Studienbeginn (RR 46%; 95%-KI: 22%; 74%), 20%iges (RR 184%; 95%-KI: 86%; 334%), 50%iges (RR 237%; 95%-KI: 84%; 715%) und 70%iges (RR 232%; 95%-KI: 65%; 571%) Ansprechen der Patienten bezogen auf die Kriterien des „American College of Rheumatology“ (ACR). Ergebnisse Arbeitsfehlzeiten und Beschäftigungsverhältnisse betreffend waren heterogen und nicht aussagekräftig. Lineare Regressionensanalysen von sowohl kontinuierlichen arbeitsbezogenen mit kontinuierlichen schmerzbezogenen Endpunkten, als auch von kontinuierlichen arbeitsbezogenen Endpunkten mit kategorischen schmerzbezogenen Ansprechraten, belegten einen statistisch signifikanten Zusammenhang. Abschließend kann berichtet werden, dass arbeitsbezogene Endpunkte nur sehr selten in placebokontrollierten Studien zu chronischen Schmerzerkrankungen untersucht wurden, und dass, wenn sie berichtet wurden, die Endpunkte und Berichterstattung heterogen waren. Es konnten wiederholt statistisch signifikante Behandlungseffekte für verschiedene arbeitsbezogene Endpunkte nachgewiesen werden. Weiterhin konnte gezeigt werden, dass eine starke lineare Relation zwischen arbeitsbezogenen Endpunkten und schmerzbezogenen Endpunkten vorliegt.

Objetivos: O objetivo do estudo foi avaliar se uma estratégia restritiva de transfusão de hemácias era superior a uma estratégia liberal na redução de mortalidade em 28 dias de pacientes oncológicos críticos com choque séptico. Desenho: unicêntrico, randomizado, duplo cego e controlado. Local: Unidade de Terapia Intensiva do Instituto do Câncer do Estado de São Paulo da Faculdade de Medicina da Universidade de São Paulo. Pacientes: Pacientes adultos com neoplasia admitidos na Unidade de Terapia Intensiva (UTI) nas primeiras 6 horas do diagnóstico de choque séptico. Intervenção: Os pacientes foram randomizados para uma estratégia liberal (transfusão de hemácias se hemoglobina < 9 g/dL) ou para uma estratégia restritiva (transfusão de hemácias se hemoglobina < 7 g/dL) durante a permanência na Unidade de Terapia Intensiva. Desfecho primário: Mortalidade por todas as causas após 28 dias. Resultados: O estudo foi realizado no período de junho de 2012 a maio de 2014. Foram randomizados 300 pacientes para as estratégias de transfusão liberal (n = 149) ou restritiva (n = 151). A mortalidade após 28 dias da randomização ocorreu em 67 pacientes do grupo liberal (45%) e em 84 pacientes do grupo restritivo (56%) (RR 1,53; intervalo de confiança 95%, 0,97-2,52, P=0,07). A mortalidade 90 dias após a randomização foi de 59% no grupo liberal e 70% no grupo restritivo (RR 1,63; intervalo de confiança 95%, 1,01-2,63; P=0,044). Os pacientes do grupo liberal receberam mais unidades de transfusão de hemácias quando comparados aos pacientes do grupo restritivo (1 [0-3] unidade vs 0 [0-2] unidade, P < 0,001). Conclusões: O estudo confirmou que uma estratégia restritiva de transfusão de hemácias quando comparada a uma estratégia liberal, não reduziu a mortalidade em 28 dias de pacientes oncológicos com choque séptico / Objective: To assess whether a restrictive strategy of red blood cell (RBC) transfusion reduces 28-day mortality when compared to a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of Intensive Care Unit (ICU) admission. Interventions: Patients were randomized to a liberal (hemoglobin threshold < 9 g/dL) or to a restrictive strategy (hemoglobin threshold < 7 g/dL) of red blood cell transfusion during ICU stay. Measurements and Main Results: The primary outcome was 28-day all-cause mortality after randomization. Between June 2012 and May 2014, 300 patients were randomized to the liberal transfusion strategy (n=149) or to the restrictive transfusion strategy (n=151) strategy. At 28 days after randomization, mortality rate in the liberal group was 45% (67 patients) compared with 56% (84 patients) in the restrictive group (hazard ratio, 1.53; 95% confidence interval, 0.97 to 2.52; P=0.07). At 90 days after randomization, mortality rate in the liberal group was 59% compared with 70% in the restrictive group (hazard ratio, 1.63; 95% confidence interval, 1.01 to 2.63; P=0.044). Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] unit vs. 0 [0-2] unit, P < 0.001). Conclusions: A restrictive strategy of RBC transfusion did not decrease 28-day mortality rate of patients admitted to ICU due to septic shock when compared to a liberal strategy

Background The World Health Organization (WHO) defines health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. Despite its importance, mental health provisions are often limited. In 2015, Indonesia had only 773 psychiatrists for 250 million residents. This shortage of specialist mental health professionals is shared by most Low- and Middle-Income Countries (LMICs) and is reflected in the Treatment Gaps in this region indicating the very small proportion of people who receive adequate mental health care for their needs. While the median worldwide Treatment Gap for psychosis is 32.2% (Kohn et al., 2004), in Indonesia it is more than 90%. Experts suggested integrating mental health care into primary care, to help bridge this gap (Mendenhall et al., 2014). The systematic introduction of the World Health Organization Mental Health Gap Action Programme into primary care clinics across Indonesia and the presence of a 15-year-old co-location of Clinical Psychologists in Yogyakarta province's primary care clinics presented an opportunity to assess the clinical and cost-effectiveness of both frameworks. Methods This research ("the trial") set out to develop an approach, and then implement it, to compare the adapted WHO mhGAP framework with the existing specialist framework within primary mental health services in Yogyakarta, Indonesia, through a pragmatic, two-arm cluster randomised controlled non-inferiority trial. This design enabled an examination of patients derived from whole populations in a 'real world' setting. The trial involved two phases: a pilot study in June 2016 with the objectives to refine data collection procedures and to serve as a practice run for clinicians involved in the trial; as well as a substantive trial beginning in December 2016. The 12-item General Health Questionnaire (GHQ-12) was established as a 'fairly accurate' screening tool using a Receiver Operating Curve study. Using the GHQ scoring method of 0-0-1-1, a threshold of 1/2 was identified for use in clinical setting, i.e. the context of the trial. The primary outcome was the health and social functioning of participants as measured by the Health of the Nation Outcome Scale (HoNOS) and secondary outcomes were disability as measured by WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality of life as measured by European Quality of Life Scale (EQ‐5D-3L), and cost of intervention evaluated from a health services perspective, which aimed to determine the clinical effectiveness and cost-effectiveness of both frameworks at six months. Results During the recruitment period, 4944 adult primary care patients attended 27 participating primary care centres. Following screening (n=1484) and in-depth psychiatric interviews (n=394), 174 WHO mhGAP arm and 151 Specialist arm participants received a formal diagnosis and were recruited into the trial. The number of required participants per treatment arm, to provide statistical power of 0.80 and statistical bilateral significance value of 0.05 was estimated to be 96. A total of 153 participants of the WHO mhGAP arm and 141 of the Specialist arm were followed-up at six months, representing 90.8% of all participants diagnosed. At follow-up, 82% (n=126) participants of the WHO mhGAP arm indicated they had attended at least one treatment session during the trial, significantly more than in the Specialist Arm (69%; n=97), 2 = 7.364, p=0.007. The WHO mhGAP arm was proven to be statistically not inferior to the Specialist arm in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Cost-effectiveness analyses show that the Specialist arm was dominant for a unit of improvement in patient outcomes at six months. While the framework is more expensive for the Health System, participants in the Specialist arm were found to have larger improvements. Conclusion Given that both frameworks yielded positive patient outcomes, there is no immediate need to increase the absolute number of specialist mental health professionals in community psychiatry (i.e. replicate the specialist framework outside Yogyakarta). As most psychologists and psychiatrists in Indonesia reside in large cities, the current systematic roll-out of the adapted WHO mhGAP framework might address the need to strengthen non-stigmatising mental health care within community contexts, reflecting the preferences of primary care patients. In districts or provinces which could afford the additional cost, however, the Specialist framework was shown to be better at improving patient outcomes than the adapted WHO mhGAP framework. Existing resources for specialist care can be arranged in a hub-and-spoke (step-up care) model where higher-level interventions are provided for those with greater needs. The proposed model would free-up resources for advanced clinical training of the specialist workforce in key areas of need while keeping specialist services accessible. Trial Registration This trial has been registered with clinicaltrials.gov since 25 February 2016, NCT02700490. Ehical Standards Full ethics approval from the University of Cambridge, UK was received on 15 December 2015 (PRE.2015.108) and from Universitas Gadjah Mada, Indonesia on 14 April 2016 (1237/SD/PL.03.07/IV/2016). A condition of ethics approval from the University of Cambridge is that the investigator is covered by indemnity insurance and that participants are insured for the period of their participation. This was provided by the University of Cambridge Trial Insurance Office (609/M/C/1510). Ethics approval from all the clusters was not required as each cluster (Puskesmas) is a local GP surgery which does not have its own ethics committee. Instead, approval to conduct research at the province of Yogyakarta including all five districts: Kota Yogyakarta, Sleman, Gunung Kidul, Kulon Progo, Bantul Districts was obtained from the Provincial Government Office (070/REG/V/625/5/2016) following ethics approvals. Written consent to participate was obtained from clinicians taking part as well as all patient-participants.

Chronic pelvic pain (CPP) is defined as constant or intermittent lower, cyclical or non-cyclical abdominal pain of at least six months’ duration. In the United Kingdom, over 1 million women suffer from CPP, with an estimated annual healthcare cost above £150 million. The aetiology of CPP is unknown in up to 50% of women, and in the remainder, the symptoms of CPP is associated with endometriosis, pelvic adhesions, irritable bowel syndrome or painful bladder syndrome. CPP is often accompanied by painful periods, pain during sexual intercourse and defaecation. Fatigue, sleep disturbances and depression are also common among this group of women. CPP asserts a heavy emotional, social and economic burden. Standard treatments such as hormonal and analgesic regimens are often associated with unacceptable side effects, even if helpful for the pain, underlining an urgent need for a satisfactory treatment. The meridian balanced method (BM) electro-acupuncture (EA) treatment (acupuncture needling + traditional Chinese medicine health consultation [TCM HC]) may be effective in managing CPP symptoms. Thus, I have completed a pilot study comprising of a three-armed randomised controlled trial (RCT), using a mixed methods research (MMR) approach, to assess the feasibility of a future large-scale RCT to determine the effectiveness of the meridian BMEA treatment on CPP in women. My hypothesis is that it is feasible to conduct such a large-scale RCT for CPP in women. The primary objectives were to determine recruitment and retention rates. The secondary objectives were to evaluate the, acceptability of the methods of recruitment, randomisation, interventions and assessment tools and any signals of effectiveness of the interventions. Thirty (30) women with CPP were randomised into three groups: BMEA treatment, TCM HC, or National Health Service standard care (NHS SC) group. The effects of my interventions were assessed by validated pain, physical and emotional functioning questionnaires, completed at weeks 0, 4, 8 and 12 of the study. Semi-structured telephone interviews and focus group discussions to explore participants’ experience of the study were conducted. Of the 59 women who were referred to the study, 30 women (51%) were randomised. There was a statistically significant difference in retention rates between the three groups. The retention rates were 80% (95% CI 74-96), in the BMEA treatment group, 53 % (95% CI 36- 70) in the TCM HC group and 87% (95% CI 63-90) in the NHS SC group. (Chi-square test, p=0.08) The attendance rates of the BMEA treatment group were 90% compared to 56% in the TCM HC group. There was a statistically significant difference (Mann-Whitney test, p=0.023) in attendance between the two intervention groups. Telephone interviews regarding the acceptability of the methods of recruitment, randomisation, assessment tools and interventions were positive. No adverse effects that were directly related to BMEA treatments were reported or observed. A higher proportion of the BMEA treatment group achieved clinical significance in the VAS-pain, BPI-pain severity, interference, and sleep scores, when compared to the other two groups. Due to small sample sizes, there was insufficient power to show statistically significant difference. (Fishers Exact Test, p=1.0) Analyses of the questionnaire data per group showed statistically significant differences in the following: the BMEA treatment group experienced less in pain at weeks 4 (p=0.01) and 8 (p=0.005); less helplessness (p=0.03) and their anxiety and depression scores declined at week 4 (p=0.04). The NHS SC group also reported less pain at week 4 (p=0.04). However, this group scored higher in anxiety and depression at weeks 8 and 12 (p=0.04). No statistically significant differences were achieved between the three groups at baseline, weeks 4, 8 and 12 in all scores. The therapeutic benefits gained by the TCM HC group were less compared to those of the BMEA treatment group, but better when compared to the NHS SC group. The BMEA treatment and TCM HC groups showed lower scores in anxiety and depression while the NHS SC group showed higher scores in anxiety and depression. The NHS SC group also tended to ruminate and magnify their problems as well as feeling more helpless than the other two groups. The three key themes that emerged from thematic analysis of focus group discussions were the “whole person effects” where participants reported an improvement in pain, sleep and a general sense of wellbeing in the two intervention groups; the “experience of standard care” and “impact of living with CPP”. In conclusion, the results of my pilot study are supportive of the feasibility of a future large-scale study. There were signals of effectiveness of interventions but the sample size was too small to make a definitive conclusion.

[Truncated abstract] Approximately 35% of women worldwide have stress incontinence, which is defined as involuntary leakage of urine on effort, exertion, or on sneezing and coughing. There are various surgical techniques for stress incontinence; however, minimally invasive operations are increasingly being chosen by surgeons and their patients. Of these procedures, tension-free vaginal tape (TVT) has a cure rate of approximately 90% and is now perceived as the standard technique for stress incontinence. Reported complications of TVT include arterial laceration, bladder perforation, bowel perforation, de novo urgency, dyspareunia, excessive blood loss, haematoma, nerve injuries, urethral erosion, urge incontinence, urinary tract infection, vascular injury, vaginal mesh erosion, voiding dysfunction and death. Suprapubic urethral support sling (SPARC) is a very similar minimally invasive operation and early indications suggested that the success rate for treating stress incontinence was expected to be identical or better than those obtained with the earlier TVT approach, with possibly fewer adverse perioperative events. Our trial sought to establish equivalence between TVT and SPARC in relation to short-term complications and efficacy. OBJECTIVES The primary outcome was bladder perforation. Secondary outcomes were blood loss, voiding difficulty, urgency, and cure of stress incontinence symptoms. METHOD A randomised controlled one-sided equivalence trial (RCT) was conducted in Perth, Western Australia during 2003 and 2004 by researchers in the School of Population Health, University of Western Australia (UWA) and King Edward Memorial Hospital (KEMH). Patients were recruited from the public Urology/Urogynaecology Clinic at the primary women's hospital and the consultant surgeons' private practices. ... However, acute urinary retention requiring a return to theatre to loosen the tape (TVT 0%, SPARC 6.5%; OR: [infinity], 95% CL: 2.2, [infinity]; p=0.002) and subjective short-term cure (TVT 87.1%, SPARC 76.5%; OR: 2.07, 95% CL: 1.13, 3.81; p=0.03) were statistically significantly different. CONCLUSIONS The results are consistent with clinical equivalence between TVT and SPARC in relation to the incidence of bladder perforation. No statistically significant difference was found between TVT and SPARC in blood loss, urgency or short-term objective cure of stress incontinence at the six week post-discharge visit to the surgeon. However, the tapes were more difficult to adjust correctly in SPARC procedures and a statistically significant number of patients required a return to theatre for loosening of the tape (TVT 0/147, 0% and SPARC 10/154, 6.5%, p=0.002). Compared with SPARC, TVT was statistically significantly higher for subjective short-term cure. In ii relation to vaginal mesh erosion, TVT was lower than SPARC, though not statistically significantly. Overall, voiding difficulty (loosening of the tape), urgency and vaginal mesh erosion were the most important clinical problems. This randomised controlled trial demonstrates the importance of testing new devices which appear to be similar, but which may have clinically relevant differences. A follow up study to assess the long-term efficacy of tension-free vaginal tape and suprapubic urethral support sling and associated complications is planned.

Stress-related diseases and burnout have increased in Sweden during the last decades. In 2006, the most common diagnoses for new cases of sickness compensation were mental and behavioural disorders in both women and men. In spite of the large group of people seeking care for and on long-term sickness absence due to stress-related diseases and burnout, there is no agreement on which treatment they should be offered. The overall aim of this thesis was to describe patients on longterm sick leave because of burnout and to evaluate rehabilitation programs for this patient group. Two patient samples were recruited from the Stress Clinic at the University Hospital in Umeå, Sweden: REST (Rehabilitation for stressrelated disease and burnout; n=136) and QIST (Qigong for stress-related disease and burnout; n=82). A general population sample was from the 2004 Northern Sweden MONICA survey (n=573). Patients in REST were randomised into a 1-year rehabilitation program to either program A (Cognitively-oriented Behavioural Rehabilitation (CBR) and Qigong), or to program B (Qigong alone). In Paper I, baseline data were compared with data from the MONICA sample. In paper II, programs A and B were compared regarding effects on psychological variables and sick leave rates, and in Paper III, 18 patients from program A and B were interviewed to explore subjective experiences of the rehabilitation programs. Patients in QIST were allocated to an intervention with Qigong twice a week for 12 weeks or a control group. Psychological and physical measurements were assessed in QIST. Data were collected by questionnaires, physical measurements, the register on sick leave, and interviews. Patients with burnout reported a more restricted social network and higher work demands than the general population. In relation to women from a general population, women with burnout more often worked “with people”, reported high job strain, a more sedentary work situation and less emotional support. A per-protocol analysis showed no significant differences in treatment effect between program A and B in REST or between the intervention and control group in QIST. All groups improved significantly over time with reduced levels of burnout, anxiety, depression, and fatigue. In REST, lower scores on obsessive-compulsive symptoms, stress behaviour, and sick leave rates were found in both programs and in QIST both groups increased dynamic balance and physical capacity. In an intention-to-treat analysis, patients in program A in REST had significantly fewer obsessive-compulsive symptoms, and larger effect sizes in stress behaviour and obsessive-compulsive symptoms compared to patients in program B. Patients in both REST programs perceived that the 1-year rehabilitation program gave them specific tools to use in secondary prevention. They also emphasised that the good encounters, affirmation and group cohesiveness they perceived during the 8 rehabilitation was a necessary basis for initiation of a behavioural change leading to recovery. In conclusion, compared to a general population, patients with burnout perceived more demands at work and less social support. Lack of emotional support seemed to be more associated with burnout among women. There were no differences in effect between CBR and Qigong compared to Qigong alone, or between a 12 week Qigong intervention compared to a control condition. Improvements were found in all groups in the rehabilitation programs. CBR combined with Qigong have some advantages compared to Qigong alone. An environment with good encounters and affirmation of the patients was experiences as important by the patients and group rehabilitation had advantages as recognition and support from the group. Early rehabilitation measures are important to prevent long-term sickness absence. In future rehabilitation programs it might be necessary to have a more individualized approach and choose treatments preferred by the patient.

The number of old people is growing and will increase future demands on healthcare services for old people. Hip fracture is one of the diagnoses that increases with age and it has become a major problem, both for those suffering a fracture and for society due to the large numbers involved, the morbidity with complications such as falls, functional decline, and the high mortality rate among those affected. The main purposes of this thesis were, to study the impact of previous hip fractures on their life among the very old, to study in-patient falls, fall-related injuries and fall-risk factors, and to evaluate a multidisciplinary, multi-factorial intervention program designed to reduce in-patient falls and to enhance functional performance among old people who have sustained a femoral neck fracture. The impact of a hip fracture was examined in a cross-sectional population-based study, among the very old (Umeå 85+). After adjustment for potential covariates, participants with a history of hip fracture were found to be more dependent in the performance of Personal/Primary Activities of Daily Living (P-ADL) (p=0.024), walked less independently (p=0.040) and used a wheelchair more frequently (p=0.017). Most of the participants with earlier hip fractures who had moved to institutional care or begun using mobility aids, as compared to before the fracture, had started to do so permanently in connection with the fracture incident. In-patient falls, fall-related injuries and fall-risk factors were studied in 97 participants, aged 70 or more, treated for a femoral neck fracture. There were 60 postoperative falls occurring among 26/97 participants (27%). Thirty-two percent of the falls resulted in injuries, 25 % were minor, and 7 % were serious. Delirium after day seven, (Hazard Rate Ratio (HRR) with a 95% Confidence Interval (CI)), 4.62 (1.30-16.37), male sex 3.92 (1.58-9.73), and sleeping disturbances 3.49 (1.24-9.86), were associated with in-patient falls. Forty-five percent of the participants were delirious on the day they fell. The effects of a multidisciplinary, multi-factorial intervention program on in-hospital falls and injuries as well as the short- and long-term effects on living conditions, walking ability and performance of activities of daily living were evaluated in a randomised controlled trial among 199 participants with femoral neck fracture, aged ≥70 years. Participants were randomised to care in a geriatric ward (intervention, n=102) or to conventional postoperative routines (control, n=97). The intervention consisted of staff education, individualized care planning and rehabilitation, systematic assessment and treatment of fall-risk factors, active prevention, and detection and treatment of postoperative complications and an intervention follow up at four-months. The staff worked in teams to apply comprehensive geriatric assessment, management and rehabilitation. Twelve participants fell a total 18 times in the intervention group compared to 26 participants suffering a total 60 falls in the control group. Only one participant with dementia fell in the intervention group compared to 11 participants with dementia in the control group. The fall incidence rate was 6.29/1000 days vs. 16.28/1000 for the intervention and control groups respectively. The Incidence Rate Ratio (IRR) was 0.38 (95% CI: 0.20-0.76, p=0.006) for the total sample and 0.07 (95% CI: 0.01-0.57, p=0.013) among participants with dementia. No new fractures were incurred in the intervention group but there were four in the control group. In addition, despite shorter hospitalization, significantly more people from the intervention group had regained independence in P-ADL performance at the four- and twelve-month follow ups, Odds Ratios (OR), with 95% CI, were 2.51 (1.00-6.30) and 3.49 (1.31-9.23) respectively. More participants in the intervention group had also regained the ability to walk independently without walking aids indoors, at the end of the study period, 3.01 (1.18-7.61). In conclusion, hip fracture among the very old seems to be associated with poorer P-ADL performance and poorer mobility. Falls and injuries are common during in-patient rehabilitation after a femoral neck fracture, delirium and sleep disturbances and male gender are factors associated with in-patient falls. Having a team apply comprehensive geriatric assessments and rehabilitation, including the prevention, detection and treatment of fall-risk factors, can successfully prevent in-patient falls and fall-related injuries, even among participants with dementia, and can also enhance the performance of Activities of Daily Living (ADL) and mobility after a hip fracture, in both short- and long-term perspectives.